PHSS Sterile Product Manufacturing Conference, March 2024

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In March 2024,  I attended on behalf of LGZ Quality Services Ltd,  the 1.5-day Sterile Product Manufacturing and Aseptic Conference, organised by PHSS, the Pharmaceutical & Healthcare Sciences Society. 

The conference was packed with really interesting talks by subject matter experts within the Pharma and Biopharma industry, presenting the following topics:

• Challenges to particulate counter installation and qualification to manage particle loss in sampling and strategies to address them, by Julian Kay from GSK
• Implementation of a new isolator-based filling line for sterile fill-finish of vial vectors, by Leslie Southam from Oxford Biomedica
• Practical validation/application of Enzyme Indicators in vH202 surface decontamination, by Birte Scharf from Franz Ziel GmbH
• Forming confident connections in fluid pathway, by Katie Church from Watson Marlow
• Regulatory Insights discussions, by Malcolm Holmes from PHSS
• Panel’s perspective, including MHRA and leading SMEs to answer any questions
• MHRA views on GMP impact and assessment processes, by Martine Powell, MHRA Expert GMP Inspector
• Risk management of contaminants in gowning in future sites, by Matts Ramstrop from BioTekPro
• Flexible manufacturing – facilities for multiple processes and scales, by Andrew Besso from eXmoor Pharma
• Annex I and ISO TR14644-21, by Gordon Farquharson from Critical Systems Ltd
• Challenges with transferring to ATMP, by Tamryn Hassel
• Rapid methods vs. conventional implementation, by Tim Sandle, BPL
• VR presentation and demonstration, by Stephen Steward from Catapult GCT
• Annex I updates – QRM principles and risk based holistic implementation, by Di Morris, PHSS/PNR/Pharma (ex-MHRA)

Thank you to all speakers, organisers and attendees for such an insightful and inspiring time. These types of events are really important for the industry and for consultants to gain a better awareness, understanding or further insights into key challenging topics and emerging technologies and regulations as well as an opportunity for networking.

Lara Gonzalez-Ruiz - Director of LGZ Quality Services Ltd